spk-logo-white-text-short2
0%
1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

Integrating Medical Device Product Development with the Quality Management System

medical device industry image blood cells in vein
Written by SPK Blog Post
Published on July 3, 2013

A critical business challenge for medical device manufacturers as they scale is getting products to market quickly while supporting existing products and meeting FDA Quality System Regulation (21-CFR-820) requirements. To achieve this effectively, Product Development must be integrated with a Quality Management System.

Let’s look at a typical business scenario:

Complaint Scenario

Consider how many different workflow processes and were touched in this one example. How much time was spent searching for information in different systems?  How many people were required to key in information manually into multiple tools?

Siloed processes implemented with point solutions inevitably fail to scale. No single point solution suite can meet 21-CFR-820 requirements completely as they ignore critical interactions between product design, quality and manufacturing:

Siloed Point Solutions

As disparate data stores for CAD files, DHFs, DMRs, CAPAs, NCRs, to name a few, grow rapidly, they become increasingly difficult to migrate and integrate.

This increases the risk of adverse business impacts like delayed product launches, product recalls, FDA 483s and warning letters and we hear:

  • Engineers are spending more time on paper work than product design!”
  • “Pulling documents for an FDA audit or a 510k submission is a nightmare!”
  • “We are spending more and more on IT tools but we still can’t find the right information!”

These issues can be mitigated by adopting a comprehensive Product Lifecycle Management (PLM) solution that spans the entire product development process as well as most of the quality systems processes.  Additionally, end-to-end PLM solutions reflect industry best practices thus helping to increase the organization’s process maturity.

Next Steps:

Latest White Papers

The Role of AI in Modernizing Manufacturing Operations

The Role of AI in Modernizing Manufacturing Operations

AI and machine learning play a critical role in modern manufacturing. AI integration helps create more efficient workflows through automation. Along with automation, manufacturers can also use these tools to create predictive analytics from customer data to anticipate...

Related Resources

The Key to Reducing Costs and Improving Product Quality

The Key to Reducing Costs and Improving Product Quality

Introduction Michael Roberts: Hello and welcome to this SPK Vlog entitled The Key to Reducing Costs and Improving Your Quality. My name is Michael Roberts, Vice President of Sales and Marketing here at SPK and Associates. I'm here today with Daniela. Feel free to...

Strategic Partners, Not Just Extra Hands

Strategic Partners, Not Just Extra Hands

Today’s business environment requires companies to align with best-in-class vendors to be true, strategic partners.  They need partners who understand their industry, their challenges, and their long-term goals.  In the years we have partnered with our clients, some...